Dupixent recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis

The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In June 2022, Dupixent was approved by the FDA for children in this age group.

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, crusting and oozing, which can increase the risk of skin infection. Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Current treatment options in this age group are primarily topical corticosteroids (TCS), which can be associated with safety risks and may impair growth when used long-term.

The positive CHMP opinion is supported by data from a Phase III trial in children 6 months to 5 years of age recently published in The Lancet,(previously cited) which met all primary and secondary endpoints. At 16 weeks, Dupixent plus low-potency TCS improved skin clearance and reduced overall disease severity compared to TCS alone (the placebo arm). Dupixent patients also experienced reduced itch and skin pain as well as improved sleep quality and health-related quality of life compared to placebo. Long-term data further showed a sustained improvement in these disease measures up to one year. Safety results were generally consistent with the known safety profile of Dupixent in atopic dermatitis. Adverse events more commonly observed with Dupixent in this atopic dermatitis population compared to placebo included conjunctivitis and eosinophilia.